Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033475
First received: April 9, 2002
Last updated: December 18, 2013
Last verified: June 2002

April 9, 2002
December 18, 2013
March 2001
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  • Complete response [ Designated as safety issue: No ]
  • Partial response [ Designated as safety issue: No ]
  • Stable disease [ Designated as safety issue: No ]
  • Progressive disease [ Designated as safety issue: No ]
  • Time to complete remission [ Designated as safety issue: No ]
  • Survival at 2 years [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00033475 on ClinicalTrials.gov Archive Site
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Reduced Immunosuppressive Therapy With or Without Donor White Blood Cells in Treating Patients With Lymphoproliferative Disease After Organ Transplantation
Cytotoxic T Cell Therapy for Post Transplant Lymphoproliferative Disease: Randomized Controlled Trial in Transplant Recipients

RATIONALE: Some types of lymphoproliferative disease are associated with Epstein-Barr virus. Combining reduced immunosuppressive therapy with donor white blood cells that have been treated in the laboratory to kill cells infected with Epstein-Barr virus may be an effective treatment for lymphoproliferative disease.

PURPOSE: Randomized phase III trial to compare the effectiveness of reducing immunosuppressive therapy with or without donor white blood cells in treating patients who have Epstein-Barr virus-associated lymphoproliferative disease after organ transplantation.

OBJECTIVES:

  • Determine the efficacy of treatment with partially HLA-matched allogeneic cytotoxic T cells and reduction of immunosuppression, in terms of survival rate and time to remission in patients with Epstein-Barr virus-associated B-cell lymphoproliferative disease after solid organ transplantation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to transplanted organ type and transplant center. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo sliding-scale reduction of immunosuppressive drugs from 1 of 5 regimens at physician's discretion. Patients then receive partially HLA-matched allogeneic cytotoxic T cells IV over 5 minutes once weekly for a total of 4 weeks.
  • Arm II: Patients undergo reduction of immunosuppression as in arm I alone. Patients are followed monthly for 6 months and then every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Lymphoproliferative Disorder
Biological: therapeutic allogeneic lymphocytes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
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DISEASE CHARACTERISTICS:

  • Diagnosis of post-transplant lymphoproliferative disease (PTLD) after solid organ (heart, heart/lung, liver, liver/gut, pancreas, or kidney) transplantation

    • Epstein-Barr virus-positive tumor
    • Newly diagnosed disease
  • Measurable disease by clinical methods or radiography
  • Must have partially matched donor cytotoxic T cells (CTL) available
  • No known panel reactivity to any of the HLA types of CTL available for therapy

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Karnofsky 20-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified

Other:

  • No prior therapy for PTLD
  • No concurrent antiviral drugs (e.g., acyclovir or ganciclovir) for PTLD
Both
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No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00033475
CDR0000069288, CRUK-EBV-CTL, LCMV-CTL, EU-20057
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University of Edinburgh
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Study Chair: Dorothy H. Crawford, MD University of Edinburgh
National Cancer Institute (NCI)
June 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP